Rhinoplasty appliance and method of forming the same

ABSTRACT

A rhinoplasty appliance is provided that may be custom-molded to a patient&#39;s nasal anatomy, including the nostrils, to maintain the corrected contour of the nostrils after rhinoplastic surgery. The rhinoplasty appliance may include a support wire; a first and second wire flanges; a first and second nostril insertion portions, each having a passage and an aperture to permit flow of air and drainage; a connecting structure to maintain the position of the nostril insertion portions in relation to each other, and to provide support and protection for the columella. The first and second wire flange may help to secure the rhinoplasty appliance in position on the patient&#39;s face, and improve retention of the first and second nostril insertion portions in the patient&#39;s nostrils. The support wire may be provided as added support for the connecting structure.

CROSS-REFERENCE TO A RELATED APPLICATION

This application claims the benefit of U.S. provisional application Ser.No. 61/841,504, filed Jul. 1, 2013, which is incorporated herein byreference in its entirety.

BACKGROUND

Cleft palate is one of the most common craniofacial disorders, with aprevalence of 1/700 live births. Craniofacial problems are not only ofskeletal nature, but may also involve musculature and soft tissue.

Clinicians, particularly plastic surgeons, face difficulties inmaintaining the corrected shape and size of the human nostril followingsurgery in patients with cleft lip and/or palate, cranio-facialabnormalities and the like. For example, the forces of scar contracturemay lead to stenotic nostrils. In many such cases, after surgery, anasal stent of a fixed size dependent on the patient's specificmeasurements and nostril configuration may be inserted and retained inthe nasal cavity.

Previously, round tubes were used following surgery to resist nasalstenosis. However, such round tubes have proven unsuitable aestheticallybecause they promote healing of the nostril with a round shape, which isunappealing since the normal nostril shape is not truly round.

To address this problem, soft silicone rubber stents, tubes or scaffoldshave been specifically made for the human nostril shape. These stentstend to easily fall out or be extruded in use, particularly in children.They may be retained in proper placement with transseptal sutures, butsutures may be uncomfortable or may have complications. Even with theuse of suture retention, these stents typically are not retained inplace in children for longer than a few weeks. Additionally, cases havebeen reported where the transseptal sutures have cut through thecolumella.

Therefore, there is currently an unmet need for a rhinoplasty appliancefor use after surgery that protects the columella and nasal nostrilswhile improving and maintaining the desired shape and form of the nasalnostril. It is also desirable to provide such a rhinoplasty appliancethat is more comfortable, easy to make, and not easily extruded when inuse.

BRIEF SUMMARY

The subject invention provides a rhinoplasty appliance that iscustom-molded to a patient's nasal nostrils to maintain the correctedcontour of the nostrils after rhinoplastic surgery. The subjectinvention further provides methods of using the rhinoplasty appliance.The rhinoplasty appliance is, advantageously, easy and inexpensive tomanufacture from readily available materials, such as metals andthermoplastic materials.

In a specific embodiment, a rhinoplasty appliance which may be removablyinserted within the nostrils of a patient may have a first and secondnostril insertion portions, a connecting structure, and a first andsecond flange. The nostril insertion portions may each have a passageand an aperture to permit flow of air and drainage. The connectingstructure may couple the first and second nostril insertion portions toeach other. The first flange may be affixed to the first nostrilinsertion portion, and the second flange may be affixed to the secondnostril insertion portion. The first and second flanges may each have afastener.

The first and second nostril insertion portions and the connectingstructure may be integrally molded of a thermoplastic material. Thefirst and second nostril insertion portions and the connecting structuremay be customized to fit the patient's nostrils. The connectingstructure may also have a support wire, which may be stainless steel.The first and second flanges may be made of resilient material, whichmay also be stainless steel. The fastener may be, for example, a loop, ahook, or at least one adhesive. The rhinoplasty appliance may also havea therapeutic agent. The apertures of the first and second nostrilinsertion portions may have an elliptical shape. At least one cannulamay be inserted through an aperture and extend into a passage.

The subject invention includes methods for maintaining the patency ofnostril structure following corrective surgery. In one such method, arhinoplasty appliance may be formed by making an impression of the nasalcavity of a patient; forming a mold from the impression, including afirst and second nasal nostrils and a columella; placing a liquid resinmix within the first and second nasal nostrils and around the columellaof the mold; inserting a support wire, a first and second flanges, and afirst and second aperture spacers into the resin mix before the mixsets; and after the mix sets, removing the first and second aperturespacers. The resin mix may be a thermoplastic acrylic resin.

In another method, a rhinoplasty appliance may be provided to a patient,a first and second nostril insertion portions may be inserted into thepatient's nostrils; the first and second wire flanges may be retained inposition on the patient's face; and the rhinoplasty appliance may beworn to maintain at least one nostril structure. The patient may be ahuman baby, infant, child, adolescent, or adult. The rhinoplastyappliance may be worn continuously for about two to three monthsfollowing corrective surgery. After wearing the rhinoplasty appliancecontinuously for about two to three months, the rhinoplasty appliancemay be worn at night for about four to six months. The first and secondflanges may be retained on the patient's face using elastic bands oradhesive.

BRIEF DESCRIPTION OF DRAWINGS

In order that a more precise understanding of the above-recitedinvention can be obtained, a more particular description of theinvention briefly described above will be rendered by reference tospecific embodiments thereof that are illustrated in the appendeddrawings. The drawings presented herein may not be drawn to scale andany reference or implication of dimensions in the drawings or thefollowing description are specific to the embodiments disclosed. Anyvariations of these dimensions that will allow the subject invention tofunction for its intended purpose are within the scope of the subjectinvention. Thus, these drawings depict only specific embodiments of theinvention and are not limiting in scope.

FIG. 1 shows a top perspective view of an embodiment of the subjectinvention.

FIG. 2 shows a front view of a portion of the face of a typical patientwith the embodiment of FIG. 1 inserted and retained in place in thepatient's nostrils.

FIG. 3 shows a mold from a patient's nose.

FIG. 4 shows the manner of pouring the resin mix from which theembodiment of FIG. 1 is formed.

FIG. 5 shows an exploded perspective view of the mold of FIG. 4.

FIG. 6 shows an exploded view of the embodiment of FIG. 1 once set andremoved from the mold of FIG. 5.

DETAILED DISCLOSURE

The term “patient” as used herein, refers to a mammal, preferably ahuman, to which the present invention is applied. Those that can benefitfrom the disclosed rhinoplasty appliance include, but are not limitedto, neonates, infants, children, adolescents and adults.

References to “first”, “second”, and the like (e.g., first and secondsecuring wire), as used herein, and unless otherwise specificallystated, are intended to identify a particular feature of which there areat least two. However, these references are not intended to confer anyorder in time, structural orientation, or sidedness (e.g., left orright) with respect to a particular feature.

With reference to the drawings wherein like reference charactersdesignate like or corresponding elements throughout the several views,it will be seen that the invention comprises a rhinoplasty applianceshown generally at 10.

In the embodiment shown in FIG. 1, a rhinoplasty appliance 10 comprisesa first and second nostril insertion portions 15 a, 15 b and aconnecting structure 20, all of which are preferably integrally moldedfrom an elastomeric and/or thermoplastic material (e.g., silicone,rubber, plastic). Preferably, the thermoplastic material is an acrylicresin. Even more preferably, the acrylic resin is derived from anorthodontic resin powder and liquid as more fully described laterherein.

The first and second insertion portions 15 a, 15 b are generallyidentical in shape and size and each include a passage and an aperture25 a, 25 b to ensure air flow and drainage when in use. The first andsecond insertion portions 15 a, 15 b are custom formed to fit within thenostrils of the patient and conform to the internal shape thereof Incertain embodiments, the first and second insertion portions are roughlybetween about 1 to 25 mm in length, more preferably about 3 to 15 mm inlength; and roughly between about 1 to 15 mm in diameter, morepreferably about 3 to 7 mm in diameter. As understood by the skilledartisan, the size and shape of the first and second insertion portionsare customized to the patient and the lengths and diameters of theinsertion portions will vary.

The connecting structure 20 comprises a support wire 30. The first andsecond insertion portions 15 a, 15 b each comprise wire flanges 35 a, 35b. The support wire 30 and the wire flanges 35 a, 35 b may be made ofresilient, semi-rigid or rigid material (e.g., metal). Preferably, thesupport wire 30 and the wire flanges 35 a, 35 b can be made of stainlesssteel. The diameter of the stainless steel wire is about 0.5mm to about1.5 mm, more preferably approximately 0.9 mm.

The support wire 30 is formed with a series of bends 40 in order toanchor the same firmly within the connecting structure 20 while it sets.The wire flanges 35 a, 35 b are formed with bends 45 at the proximalends to anchor the same within the insertion portions 15 a, 15 b. Thedistal ends of the wire flanges 35 a, 35 b terminate in a small loop orhook 50 to assist in securing the appliance 10 to the patient and toavoid a sharp end which could cut or damage the patient or surgeon.

As illustrated in FIG. 2, the first and second insertion portions 15 a,15 b are formed to fit within the nostrils of the patient. In certainembodiments, adhesives are placed at the distal ends of the wire flanges35 a, 35 b to secure the appliance 10 to the patient's face and preventwithdrawal or expulsion of the insertion portions 15 a, 15 b from thepatient's nostrils. In addition, or alternatively, one or more elasticbands are placed in the loops 50 to assist securing the appliance 10 tothe patient's face. In a related embodiment, a single elastic band maybe used to connect the distal ends of the wire flanges 35 a, 35 b tosecure the appliance to the patient's head. As understood by the skilledartisan, due to differences in patient faces, the lengths of the wireflanges will vary to ensure proper fixation to the patient's face

The rhinoplasty appliance can further comprise a therapeutic agent.Therapeutic agents may be incorporated in the appliance or may beprovided on the surface of the appliance. Examples of therapeutic agentsinclude, but are not limited to, antibiotics and other medications.

Proper fit and retention is very important since the rhinoplastyappliance may be worn for many months both at night and during the day.To enhance patient comfort and fit of the rhinoplasty appliance, severalof the most likely sizes and dimensions may be made in advance, or therhinoplasty appliance may be individually customized to each patient.Some examples may include providing rhinoplasty appliances having morethan one range of sizes, which may roughly correspond to patients whomay be characterized as neonatal, pediatric, or adolescent. In a firstspecific example, a neonatal rhinoplasty appliance may have a length ofapproximately 8-10 mm, a height of approximately 5-7mm, and a width ofapproximately 4-5 mm. In a second specific example, a pediatricrhinoplasty appliance may have a length of approximately 10-12 mm, aheight of approximately 8-10 mm, and a width of approximately 6 mm. In athird specific example, an adolescent rhinoplasty appliance may have alength of approximately 10-15 mm, a height of approximately 11-13 mm,and a width of approximately 7 mm. All of the dimensions of eachspecific example may be adjusted by a millimeter or more to better fitthe patient's anatomy.

The rhinoplasty appliance described above is of primary importance inrestoring the nostril size and shape, especially for patients with cleftlip or crania-facial anomalies. With conventional nasal stents, the sameare used for no more than one week post surgery and in many cases, thenasal tissue may collapse and will not permit optimal aesthetic results.

The rhinoplasty appliance may also be used with patients requiring anasal cannula, such as a medical tube providing oxygen. The appliancemay be used to protect the columnella during insertion of a cannulathrough an aperture and extending into a passage.

In order to custom-form the rhinoplasty appliance, an impression of thepatient's nose is taken using any orthodontic or similar mold castingmaterial, see FIG. 3. The resulting mold 100 serves as a reservoir intowhich a mixture of orthodontic resin powder and liquid 105 may be pouredas shown in FIG. 4. Specifically, the mold provides an impression of thepatient's nostrils and columella to which the resin mixture is applied.

Before the resin mix is poured into the mold or before the resin mixsets, a support wire 30, wire flanges 35 a, 35 b and aperture spacers 60are inserted in the mold, see FIG. 5. Aperture spacers 60 are employedto ensure a passage and opening are formed in the nostril insertionportions 15 a, 15 b to permit flow of air and drainage. Once the resinmix is set, the entire assembly is removed from the mold as shown inFIG. 6 and the spacers 60 may be removed.

To maintain the patency of nostril structure following surgery, thesubject rhinoplasty appliance is provided. The nostril insertionportions are inserted into a patient's nostrils and the wire flanges areaffixed to the patient's face following corrective surgery. During thefirst period of healing, the rhinoplasty appliance is used 24 hours aday. Preferably, the rhinoplasty appliance is used 24 hours a day forabout two to three months. During this period, intermittent visits canbe conducted with a clinician for any revisions or adjustments to therhinoplasty appliance. Following this period, the rhinoplasty applianceis worn only at night. Preferably, the rhinoplasty appliance is worn atnight for about four to six months. Because recurrence of nostrilstenosis and other nostril shape abnormalities may occur, overcorrectionis recommended.

All patents, patent applications, provisional applications, andpublications referred to or cited herein are incorporated by referencein their entirety, including all figures and tables, to the extent theyare not inconsistent with the explicit teachings of this specification.

It should be understood that the examples and embodiments describedherein are for illustrative purposes only and that various modificationsor changes in light thereof will be suggested to persons skilled in theart and are to be included within the spirit and purview of thisapplication and the scope of the appended claims. In addition, anyelements or limitations of any invention or embodiment thereof disclosedherein can be combined with any and/or all other elements or limitations(individually or in any combination) or any other invention orembodiment thereof disclosed herein, and all such combinations arecontemplated with the scope of the invention without limitation thereto.

What is claimed is:
 1. A rhinoplasty appliance for removable insertionwithin the nostrils of a patient comprising: a first and second nostrilinsertion portions, each having a passage and an aperture to permit flowof air and drainage; a connecting structure coupling the first andsecond nostril insertion portions; and a first flange affixed to thefirst nostril insertion portion, and a second flange affixed to thesecond nostril insertion portion; wherein the first and second flangeseach have a fastener.
 2. The rhinoplasty appliance according to claim 1,wherein the first and second nostril insertion portions and theconnecting structure are integrally molded of a thermoplastic material.3. The rhinoplasty appliance according to claim 1, wherein the first andsecond nostril insertion portions and the connecting structure arecustomized to fit the patient's nostrils.
 4. The rhinoplasty applianceaccording to claim 1, wherein the connecting structure further comprisesa support wire.
 5. The rhinoplasty appliance according to claim 4,wherein the support wire is stainless steel.
 6. The rhinoplastyappliance according to claim 1, wherein the first and second flanges aremade of resilient material.
 7. The rhinoplasty appliance according toclaim 6, wherein the first and second flanges are stainless steel. 8.The rhinoplasty appliance according to claim 1, wherein the fastener isselected from the group consisting of: a loop, a hook, and one or moreadhesives.
 9. The rhinoplasty appliance according to claim 1, furthercomprising a therapeutic agent.
 10. The rhinoplasty appliance accordingto claim 1, wherein the aperture of the first and second nostrilinsertion portions has an elliptical shape.
 11. The rhinoplastyappliance according to claim 1, further comprising at least one cannulainserted through an aperture and extending into a passage.
 12. A methodof forming a rhinoplasty appliance including the steps of: (a) making animpression of the nasal cavity of a patient, (b) forming a mold fromsaid impression, which includes a first and second nasal nostrils and acolumella, (c) placing a liquid resin mix within the first and secondnasal nostrils and around the columella of the mold, (d) inserting asupport wire, a first and second flanges, and a first and secondaperture spacers into the resin mix before the mix sets, and (e) afterthe mix sets, removing the first and second aperture spacers.
 13. Themethod of claim 12, wherein the resin mix is a thermoplastic acrylicresin.
 14. A method of maintaining at least one nostril structurefollowing corrective surgery, comprising: (a) providing a rhinoplastyappliance according to claim 1 to a patient; (b) inserting the first andsecond nostril insertion portions into the patient's nostrils; (c)retaining the first and second wire flanges in position on the patient'sface; and (d) wearing the rhinoplasty appliance to maintain at least onenostril structure.
 15. The method of claim 14, wherein the patient ishuman and selected from the group consisting of: neonate, infant, child,adolescent, and adult.
 16. The method of claim 14, wherein therhinoplasty appliance is worn continuously for about two to three monthsfollowing corrective surgery.
 17. The method of claim 16, whereinfollowing wearing the rhinoplasty appliance continuously for about twoto three months, the rhinoplasty appliance is worn at night for aboutfour to six months.
 18. The method of claim 14, wherein the first andsecond flanges are retained on the patient's face using elastic bands oradhesive.
 19. The method of claim 13, further comprising inserting atleast one cannula through an aperture and into a passage.